FAPI PET/CT scans to stage pancreatic and stomach or esophagus cancer
Tests a faster PET/CT scan using [68Ga]Ga-FAPI-46 in adults with these cancers.
Plain-language title generated from the registry record
Registry title: BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 2
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Barbara Malene Fischer
- Trial code
- NCT07629609EU 2023-503632-41-01
- Record updated
- 5 June 2026
- Original description
The goal of this clinical trial is to learn if [68Ga]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that [68Ga]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups.Read full original descriptionShow less
[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer
The goal of this clinical trial is to learn if [68Ga]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that [68Ga]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups.
The main questions the trial aims to answer are:
* Is [68Ga]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities? * Can [68Ga]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min?
Researchers will examine three different patient groups:
Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy).
Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment.
Participants will undergo:
* One [68Ga]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2). * Participants in group B2 will also undergo a second [68Ga]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy. * All participants will fill out one questionnaire. * Researchers will follow the patients after the scans for 1 year.
Inclusion: Male or female, over 18 years old; Patients with suspected pancreatic cancer based on morphological findings on standard imaging; CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases; Subjects must have been considered suitable for curative surgery at the time of the referral; Subjects must be able to read and understand the patient information in Danish to give informed consent; Male or female over 18 years old; Histological verified carcinoma from the lower esophagus, GEJ, or stomach; Subjects must be considered operable and resectable at the time of referral for MDT; Subjects must be able to read and understand the patient information in Danish to give informed consent; Male or female over 18 years old; Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach; Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment; Subjects must be able to read and understand the patient information in Danish to give informed consent.
Exclusion: History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46; Pregnancy or lactation; Weight more than the maximum limit of a PET/CT-scanner bed (140 kg).